FDA Approvals Roundup: Rybrevant, Lymphoseek, Opdivo

RoundupsRoundups | 26 May 2021 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Rybrevant nabs accelerated approval for metastatic NSCLC with EGFR mutations
Janssen’s Rybrevant (amivantamab-vmjw injection) has been granted accelerated approval for treating locally advanced or metastatic non‒small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed despite chemotherapy.
Guardant’s Guardant360® CDx received concurrent approval as a companion diagnostic for Rybrevant, a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors.
Rybrevant’s approval was based on efficacy findings in the multicenter, nonrandomized, open label, multicohort CHRYSALIS trial in 81 patients from the indicated population. Patients received Rybrevant until disease progression or unacceptable toxicity. The main efficacy outcome measures were overall response rate (ORR) according to RECIST 1.1 as evaluated by blinded independent central review and response duration. The ORR was 40% and median duration of response (DoR) 11.1 months.
The indication received accelerated approval based on the ORR and DoR. Its continued approval is contingent on follow-up verification and description of clinical benefits in confirmatory trials.
The review used the assessment aid and was conducted under Project Orbis in collaboration with the Brazilian Health Regulatory Agency and the UK Medicines and Healthcare products Regulatory Agency.
Rybrevant was granted breakthrough therapy designation for this indication.
New indications
Lymphoseek use expanded to include pediatric patients
Cardinal Health’s Lymphoseek (tilmanocept injection) has received an new indication for locating nodes draining a primary tumor site in pediatric patients aged 1 month or older with solid tumors.
Lymphoseek can be used with or without scintigraphic imaging for lymphatic mapping with a handheld gamma counter. The procedure is part of intraoperative management.
Lymphoseek was originally approved in 2013 as a radioactive diagnostic agent for adults, used with or without scintigraphic imaging, for locating lymph nodes draining a primary tumor site in patients with solid tumors or guiding sentinel lymph node biopsy in patients with squamous cell carcinoma of the oral cavity, breast cancer, or melanoma.
Opdivo picks up expanded indication for resected esophageal or GEJ cancer
Bristol-Myers Squibb’s Opdivo (nivolumab injection) has been granted a new indication for the treatment of patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received previous chemoradiotherapy.
Approval of the expanded indication for Opdivo, a programmed death receptor-1 (PD-1)-blocking antibody, was based on efficacy findings from the randomized, multicenter, double-blind CHECKMATE-577 trial in 794 patients from the indicated population. They were randomized 2:1 to receive Opdivo or placebo for up to one year. Disease-free survival (DFS) was the main efficacy outcome. Findings demonstrated a statistically significant improvement in DFS for the study drug patients compared with those receiving placebo (22.4 versus 11 months, respectively; hazard ratio, 0.69; 95% confidence interval, 0.56-0.85; P = .0003). That benefit was independent of tumor PD-L1 expression and histology.
The review for this indication was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration, Health Canada, and Swissmedic. It also used the real-time oncology review pilot program and the assessment aid.
Opdivo received orphan drug designation for the new indication. It was originally approved in 2014 and is used to treat several types of cancers, including melanoma, colorectal cancer, and classical Hodgkin lymphoma.
Yervoy gets extended indication for use in advanced melanoma
Bristol-Myers Squibb’s Yervoy (ipilimumab injection), in combination with nivolumab, has been granted a new indication for treating adults unresectable or metastatic melanoma.
Yervoy was originally approved in 2011 and is used to treat several types of cancers, including renal cell carcinoma, NSCLC, and hepatocellular carcinoma.



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Tags: FDA, US

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